dialysis patients
Conditions
Interventions
Trade Name: KA-VIT
Product Name: KA-VIT
Pharmaceutical Form: Oral drops, emulsion
INN or Proposed INN: PHYTOMENADIONE
CAS Number: 84-80-0
Current Sponsor code: PHYTOMENADIONE
Other descriptive name: V
phylloquinone
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Sponsors
RWTH Aachen University represented by the rector, himself represented by the dean of the Medical Faculty
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female = 18 years of age - Not less than 6 months on hemodialysis - Calcification score > 100 - Written consent to take part in the study - Expectation of life not less than 18 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 114 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 234
Exclusion criteria
Exclusion criteria: - Intake of Vitamin K - History of thrombosis (except shunt occlusion) - Intake of Vitamin K antagonists (e.g. Marcumar®) - Inflammatory bowel disease - tumor disease - Short-bowel-syndrome - Liver dysfunction - anemia (Hb 100/min (resting heart rate) - Women who are pregnant or breastfeeding - Women without sufficient contraception - Alcohol or drug abuse - Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study - Subject unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up-visits, and unlikelihood of completing the study - Participation in a parallel clinical trial or participation in another clinical trial within the last 3 months - Subjects who are in any state of dependency to the sponsor or the investigators - Employees of the sponsor or the investigators - Subjects who have been committed to an institution by legal or regulatory order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Attenuation of the progression of coronary and aortic calcification;Secondary Objective: Reduction of mortality Reduction of major cardiovascular adverse events (MACE);Primary end point(s): - Aortic calcification (volume score) - Coronary artery calcification (volume score) ;Timepoint(s) of evaluation of this end point: +0, +12, +18 months based on start of vitamin k supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Aortic calcification (Agatston score) - Coronary artery calcification (Agatston score) - Calcification of aortic valve - Calcification of mitral valve - Major adverse cardiovascular events - Mortality;Timepoint(s) of evaluation of this end point: +0, +12, +18 months based on start of vitamin k supplementation | — |
Countries
Belgium, Germany
Contacts
Public ContactCTC-A
Center for Translational & Clinical Research Aachen
Outcome results
None listed